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    The acute and late toxicity results of a randomized phase II dose-escalation trial in non-small cell lung cancer (PET-boost trial)

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    Authors
    van Diessen, DJ
    De Ruysscher, D
    Sonke, JJ
    Damen, E
    Sikorska, K
    Reymen, B
    van Elmpt, W
    Westman, G
    Fredberg, PG
    Dieleman, E
    Bjorkestrand, H
    Faivre-Finn, Corinne
    Belderbos, J
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    Affiliation
    Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
    Issue Date
    2018
    
    Metadata
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    Abstract
    BACKGROUND AND PURPOSE: The PET-boost randomized phase II trial (NCT01024829) investigated dose-escalation to the entire primary tumour or redistributed to regions of high pre-treatment FDG-uptake in inoperable non-small cell lung cancer (NSCLC) patients. We present a toxicity analysis of the 107 patients randomized in the study. MATERIALS AND METHODS: Patients with stage II-III NSCLC were treated with an isotoxic integrated boost of ?72?Gy in 24 fractions, with/without chemotherapy and strict dose limits. Toxicity was scored until death according to the CTCAEv3.0. RESULTS: 77 (72%) patients were treated with concurrent chemoradiotherapy. Acute and late ?G3 occurred in 41% and 25%. For concurrent (C) and sequential or radiotherapy alone (S), the most common acute ?G3 toxicities were: dysphagia in 14.3% (C) and 3.3% (S), dyspnoea in 2.6% (C) and 6.7% (S), pneumonitis in 0% (C) and 6.7% (S), cardiac toxicity in 6.5% (C) and 3.3% (S). Seventeen patients died of which in 13 patients a possible relation to treatment could not be excluded. In 10 of these 13 patients progressive disease was scored. Fatal pulmonary haemorrhages and oesophageal fistulae were observed in 9 patients. CONCLUSION: Personalized dose-escalation in inoperable NSCLC patients results in higher acute and late toxicity compared to conventional chemoradiotherapy. The toxicity, however, was within the boundaries of the pre-defined stopping rules.
    Citation
    van Diessen J, De Ruysscher D, Sonke J-J, Damen E, Sikorska K, Reymen B, et al. The acute and late toxicity results of a randomized phase II dose-escalation trial in non-small cell lung cancer (PET-boost trial). Radiotherapy and Oncology. 2018 Oct.
    Journal
    Radiother Oncol
    URI
    http://hdl.handle.net/10541/621355
    DOI
    10.1016/j.radonc.2018.09.019
    PubMed ID
    30327236
    Additional Links
    https://dx.doi.org/10.1016/j.radonc.2018.09.019
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.radonc.2018.09.019
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